BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPNC LASER SHEATH

    MDR report key: 1575059 · Received January 8, 2010

    Report

    Report Number
    1721279-2009-00065
    Event Type
    Injury
    Date Received
    January 8, 2010
    Date of Event
    December 28, 2009
    Report Date
    January 7, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: ACUTE INFECTION. PROCEDURE: THIS WAS A LEFT-SIDED PROCEDURE PERFORMED IN THE O.R., 2 ICD LEADS TO BE REMOVED (PASSIVE RV AND RA LEAD, IMPLANTED IN 2004). RV LEAD WAS REMOVED WITH THE 16F SLS WITHOUT COMPLICATION. AFTER THE RA LEAD WAS REMOVED A NOTED DROP IN THE PT'S BLOOD PRESSURE OCCURRED. CT SURGEON CONTACTED, STAT ECHO WAS PERFORMED, CARDIAC EFFUSION NOTED AND ECHO-GUIDED PERICARDIOCENTESIS WAS PERFORMED BY PRIMARY SURGEON. ANALYSIS: LOT HISTORY REVIEW FOUND NO ISSUES OR NONCONFORMANCES RELATED TO THE REPORTED EVENT. PT OUTCOME: THE PT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL PER PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH 16F SLS MFA SPECTRANETICS CORP. 500-013 C08K17A26

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention GENERATION 4 EXCIMER LASER| LLD (UNK SIZE/LOT #)